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Effect of Resveratrol on Age-related Insulin Resistance and Inflammation in Humans

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2011 by Albert Einstein College of Medicine, Inc..
Recruitment status was:  Recruiting
Information provided by:
Albert Einstein College of Medicine, Inc. Identifier:
First received: May 12, 2011
Last updated: May 16, 2011
Last verified: May 2011
The purpose of this research is to study the effects of a medication called resveratrol on the body's response to insulin (a hormone to control blood sugar), on inflammation and/or on specific cells and processes in fat tissue, and on skeletal muscle metabolism and on brain function.

Condition Intervention Phase
Type 2 Diabetes Mellitus Insulin Resistance Drug: Resveratrol Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Resveratrol on Age-related Insulin Resistance and Inflammation in Humans

Resource links provided by NLM:

Further study details as provided by Albert Einstein College of Medicine, Inc.:

Primary Outcome Measures:
  • Peripheral Insulin Sensitivity [ Time Frame: Four weeks ]
    We will measure peripheral insulin sensitivity by determining the rate of glucose uptake

Secondary Outcome Measures:
  • Hepatic insulin sensitivity [ Time Frame: 4 weeks ]
    Endogenous glucose production will be used to determine hepatic insulin sensitivity

  • Muscle mitochondrial function [ Time Frame: 4 weeks ]
    Muscle mitochondrial structure by electron microscopy and function by enzymatic assays.

  • Inflammatory and Anti-inflammatory Markers in adipose tissue [ Time Frame: 1 month ]
    Inflammatory Markers: PAI-1, IL-6, TNF-a, iNOS Anti-inflammatory Markers: Adiponectin, Arginase 1 Will be measured in plasma

  • Neuropsychological assessment [ Time Frame: pre and post clamp studies (4 weeks) ]
    Neuropsychological testing will be performed to assess cognitive function.

Estimated Enrollment: 80
Study Start Date: March 2008
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Resveratrol
Drug: Resveratrol
1,000mg twice daily for 28 days


Ages Eligible for Study:   45 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • BMI: 26-35
  • Non-smoker
  • Normal screening labs (CMC, chemistry, LFTs PT/PTT)
  • No CAD
  • Good IV access

Exclusion Criteria:

  • High cholesterol
  • <4 week history of participation in another drug trial
  • Severe hypertension
  • Heart disease
  • Liver disease of liver abnormalities
  • Cerebrovascular disease, i.e. stroke
  • CVD
  • Seizures
  • Bleeding disorders
  • Muscle disease
  • Cancer
  • HIV
  • Hepatitis (all types)
  • Mentally disabled persons
  • Pregnant women
  • Allergies to Novocaine, Lidocaine, Benzocaine
  • Subjects on the following medications:

    • Anticoagulant and antiplatelet drugs
    • Anti-epileptic drugs
    • Mexiletene
    • Quinidine
    • Cyclosporine
    • Tacrolimus
    • HIV protease inhibitors
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01354977

Contact: Stephanie Lawrence 718-430-2903

United States, New York
Albert Einstein College of Medicine Recruiting
Bronx, New York, United States, 10461
Contact: Stephanie Lawrence    718-430-2903   
Principal Investigator: Preeti Kishore, MD         
Sponsors and Collaborators
Albert Einstein College of Medicine, Inc.
  More Information

Responsible Party: Preeti Kishore, M.D., Albert Einstein College of Medicine Identifier: NCT01354977     History of Changes
Other Study ID Numbers: 2007-534
Study First Received: May 12, 2011
Last Updated: May 16, 2011

Keywords provided by Albert Einstein College of Medicine, Inc.:
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Diabetes Mellitus
Endocrin System Diseases
Therapeutic Uses

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pathologic Processes
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents
Enzyme Inhibitors
Platelet Aggregation Inhibitors
Antimutagenic Agents
Anticarcinogenic Agents processed this record on September 21, 2017